a study of asp1941 in combination with insulin in patients with type 1 diabetes mellitus

Conditions: Type 1 Diabetes Mellitus

Summary: the objective of this study is to confirm efficacy of asp1941 based on the changes in hba1c and to assess its safety in subjects with type 1 diabetes mellitus receiving asp1941 once daily in combination with insulin for 24 weeks. this study will also assess the safety/efficacy of long-term treatment (52 weeks).

this study consists of two parts. in part 1, asp1941 or placebo will be administered orally in a blind manner. in part 2, the long-term safety and efficacy of asp1941 will be evaluated in patients who have participated in the study and completed the part 1.

Eligibility criteria:
inclusion criteria: * the subject has been diagnosed with type 1 diabetes mellitus * the subject has been receiving insulin therapy for the treatment of diabetes mellitus. * the subject has not switched from an insulin product to another insulin product or switched between continuous subcutaneous insulin infusion (csii) and multiple daily injections (mdi). * the subject has an hba1c value between 7.5% and 11.0% and the difference of hba1c value is within ± 2.0%. * the subject has a fasting blood c-peptide level \< 0.6 ng/ml. * the subject has a body mass index (bmi) between 20.0 kg/m2 and 35.0 kg/m2. exclusion criteria: * the subject has type 2 diabetes mellitus. * the subject has participated in a clinical study or post marketing study of another drug or medical equipment within 12 weeks (84 days) before providing written informed consent, or is currently participating in such a study. * the subject has received treatment with asp1941 (ipragliflozin) or participated in a clinical study of asp1941 (excluding subjects who discontinued before the investigational period). * the subject participated in this study previously. * the subject has received a hypoglycemic agent other than insulin or an α-glucosidase inhibitor. * the subject has proliferative retinopathy (except for those who have undergone photocoagulation etc. and whose symptoms are stable). * the subject has experienced severe hypoglycemia. * the subject has experienced diabetic ketoacidosis. * the subject has chronic disease that requires the continuous use of corticosteroids, immunosuppressants, etc. * the subject has symptomatic urinary tract infection or symptomatic genital infection. * the subject has a history of recurrent urinary tract infection or recurrent genital infection. * the subject has a history of cerebral vascular attack, unstable angina, myocardial infarction, vascular intervention, or another serious heart disease. * the subject has a concomitant malignant tumor or a history of malignant tumor * the subject has a history of an allergy to asp1941 (ipragliflozin) and/or similar drugs (drugs possessing sglt2 inhibitory action). * the subject has psychiatric disorder that is inappropriate for participation in the study. * the subject has drug addiction or alcohol abuse. * the subject has severe infection or serious trauma, or is perioperative. * the subject has a history of medically significant renal disease such as renovascular occlusive disease, nephrectomy and/or renal transplant. * the subject has any symptoms of dysuria, anuria, oliguria, or urinary retention. * the subject has severe renal impairment or end-stage renal failure requiring dialysis. * the subject has an aspartate aminotransferase and/or alanine aminotransferase value that exceeds 2 times, or a total bilirubin value that exceeds 1.5 times the upper limit of the reference range. * the subject has uncontrolled severe hypertension. * the subject has serious gastrointestinal disease or a history of operation for serious gastrointestinal disease.

Keywords: sglt2 inhibitor asp1941 type 1 diabetes mellitus